Senior GMP Data Analytics Analyst Contractor
P
ProKidneyBiotech/Pharma
RemoteContractSenior
Salary not disclosed
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Job Details
- Experience
- Minimum of 5-10 years of experience in IT experience working in the role of business and technical analyst with the focus on data, business intelligence, and analytics projects
- Required Skills
- AWSProject ManagementPythonSQLBusiness IntelligenceETLTableauAzureMicrosoft ExcelData modelingData analyticsR
Requirements
- Bachelor’s Degree
- Minimum of 5-10 years of experience in IT working as business and technical analyst focusing on data, business intelligence, and analytics projects
- Experience working in Biotech/Pharma (Regulated Industry)
- Experience with developing requirements, design, and testing documents
- Hands-on experience with data analysis and reporting in support of Pharmaceutical GMP environment
- Understanding of GMP data sources across pharmaceutical manufacturing process and quality control testing environment sources such as Laboratory Management Information Systems, Quality Systems, Manufacturing Execution Systems, Data Historian, and other tools
- Experience with design and development and usage of data repository and analytics platforms
- Demonstrated experience managing lifecycle documentation and validation in FDA-regulated environments
- Versed in FDA/Industry regulations and policies (Part 11, Computer System Validation)
- Experience with system administration responsibilities
- Experience with helping lead data analysis and engineering projects
- GxP, Pharmaceutical Manufacturing and Quality Data (GMP data), Data analysis and reporting
- Understanding of data modeling tools
- Experience working with analytics (Python, R, Excel, Tableau, Spotfire, other reporting and analytics for manufacturing process industries)
- Experience with database (SQL) and ETL development
- Experience with cloud environments (AWS, Azure)
Responsibilities
- Analyze business needs and requirements for data and analytics to support regulatory filings
- Identify, classify, and map data sources
- Build data lineage diagram from data source to analytics ready datasets
- Determine data curation requirements to help organize, clean, manage, and maintain data so it can be used reliably for analytical use cases
- Provide support for technical activities such as building data integration, design data architecture, and data transformation and processing
- Develop data governance standards to comply with company and industry best practices
- Lead development of key project documents such as user requirements, design specifications, and configuration specifications
- Lead development of test scenarios and scripts in partnership with business, technical, and validation team members
- Lead test execution according to test protocols
- Provide support for development of standard operating procedures and other documentation required to go-Live
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